Friday, 16 September 2016

If your facility is involved in one of the following activities, it does NOT have to register with FDA.

These Facilities DON’T Have to Register

Private residences of individuals, even though food may be manufactured/processed, packed, or held in them.

Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.

Transport vehicles that hold food only in the usual course of their business as carriers.

Farms — i.e., facilities in one general location devoted to growing and harvesting crops (washing, trimming outer leaves, and cooling produce are part of harvesting) and/or raising animals (including seafood). The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

Restaurants — i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers, are not restaurants for purposes of 21 CFR Part 1, Subpart H.

Retail food establishments, such as grocery stores, delis, roadside stands that sell food directly to consumers as their primary function, meaning that annual food sales directly to consumers are of greater dollar value than annual sales to other buyers.

Nonprofit food facilities,which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. This includes central food banks, soup kitchens, and nonprofit food delivery services.

Fishing vessels that do not process fish. Such fishing vessels may engage in practices other than processing such as harvesting and transporting fish, and heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel.

Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry, or egg products."

In your operation or opinion, which of these ranks the highest as an area needing help from an external party?

As a consumer or user of food, pharmaceuticals, medical devices or cosmetics, how would you rank safety, availability and price in order of importance from left (most important) to right (least important)?